JD Supra3d
FDA announces public meeting on pediatric exclusivity and drug development
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of ...
FierceBiotech3d
Lykos still plotting path to approval for rejected MDMA therapy after 'productive' FDA meeting
In a post-market statement on Jan. 16, Lykos gave a fresh update following what it described as a “productive” meeting with the FDA on Wednesday. “We continue to chart a path forward for an ...
FiercePharma3d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
Red dye No. 3 is now banned in the US. Here’s what studies show about more common dyes
Following the ban of red dye No. 3 in the United States, experts weigh in on the potential health risks of red dye No. 40, ...
BioPharma Dive5d
Federal watchdog cites concerns with FDA’s accelerated approval process
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Medpage Today on MSN4d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
No FDA advisory meeting for Exelixis a positive, says Citi
Citi keeps a Buy rating on Exelixis (EXEL) with a $38 price target after the company announced that it has been notified by the FDA that the ...
Mena FN6d
Novamigra Tx Announces Successful Pre-IND Meeting With FDA, Paving The Way For Accelerated Clinical Development
(MENAFN- EIN Presswire) Novamigra Tx Announces Successful Pre-IND Meeting with FDA for Migraine Prophylaxis Asset VRG-145, Paving Way for Accelerated Clinical Development BUDAPEST, HUNGARY ...
Yahoo Finance10d
Diamyd Medical confirms key advances toward Accelerated Approval for Diamyd® following FDA Type C Meeting
STOCKHOLM, Jan. 10, 2025 /PRNewswire/ -- Diamyd Medical provides an update following the receipt of final meeting minutes from a positive Type C meeting with the U.S. Food and Drug Administration ...
Nasdaq10d
FDA Updates EXEL on Previously Scheduled ODAC Meeting for Cabozantinib
The FDA has now notified the company that its sNDA will no longer be the subject of discussion at the ODAC meeting. The sNDA is under FDA review and has a target action date of April 3 ...